REMS Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Plan, organize, and lead UBC project teams to ensure the timely delivery of projects that meet client requirements, staying within budget and scope.

• Oversee all facets of project execution from initiation to closure.

• Implement operational components of assigned project tasks and special initiatives.

• Manage projects in accordance with the defined scope of work and contractual budget.

• Oversee project revenue and invoicing processes.

• Ensure adherence to UBC and relevant client standard operating procedures (SOPs) throughout projects.

• Create plans and processes aimed at achieving contracted milestones, which include project management, clinical oversight, monitoring, training, communication, and compliance strategies.

• Track project advancement and compliance against established plans.

• Develop project timelines and coordinate deliverables effectively.

• Prepare meeting agendas, minutes, and action items.

• Monitor project budgets in relation to contract milestones.

• Act as the primary sponsor contact for UBC.

• Organize and facilitate both internal and external project meetings.

• Address questions from project team members.

• Supervise functional areas that support projects and lead cross-functional project teams.

• Ensure training for projects is conducted and assist with training efforts.

• Create content and lead both internal and external kickoff meetings.

• Negotiate budgets and assist in refining contract language.

• Present project details during bid defenses, client meetings, and monthly project reviews.

• Maintain project documentation in an audit-ready state.

• Participate in sponsor and regulatory audits.

• Coordinate investigator meetings.

• Assist with the development of protocols, patient/subject consent forms, Risk Evaluation and Mitigation Strategies (REMS), and associated supporting documents as necessary.

• Contribute to process improvement initiatives.

• Establish, implement, and monitor key metrics for projects and initiatives.

• Ensure the upkeep of the Trial Master File.

• Undertake Clinical Study Support (CSS) and Clinical Research Associate (CRA) responsibilities as needed.

• Execute other duties as assigned by management.

• Supervise the project team effectively.

⛳️ Requirements

• Bachelor’s Degree or equivalent experience is required.

• Previous managerial or relevant experience is essential.

• Excellent written, verbal, and non-verbal communication skills.

• Strong supervisory abilities.

• Proficient interpersonal skills.

• Excellent presentation skills.

• Ability to independently evaluate issues and/or mitigate risks using sound judgment to reach resolutions.

• Solution-oriented mindset.

• Strong understanding of regulatory requirements (e.g., Good Clinical Practice, ICH guidelines, etc.).

• Willingness to travel up to 10% as necessary.

🏝️ Benefits

• Opportunities for remote work.

• Competitive salary packages.

• Opportunities for career advancement.

• 401K plan with company match.

• Tuition reimbursement program.

• Flexible work environment.

• Discretionary Paid Time Off (PTO).

• Paid holidays.

• Employee assistance programs.

• Medical, dental, and vision insurance coverage.

• Health Savings Account (HSA) / Flexible Spending Account (FSA).

• Access to telemedicine (virtual doctor appointments).

• Wellness initiatives.

• Adoption assistance programs.

• Short-term disability benefits.

• Long-term disability coverage.

• Life insurance policies.

• Discount programs available.